Clinical Research Associate
4 weken geleden
ABOUT US
Salvia BioElectronics is a medical device company pioneering neuromodulation therapies for migraine. Salvia's unique, paper-thin implant is designed to reduce the frequency and intensity of migraine attacks by delivering gentle electrical pulses to the nerves associated with the condition. The company is currently in the clinical stage of development. In addition, Salvia is considering potential opportunities the device creates for the treatment of cluster headache and other neurological disorders. Salvia has received the Breakthrough Device Designation from the United States Food and Drug Administration (FDA), which facilitates expedited market access for devices that treat life-threatening or irreversibly debilitating conditions.
THE CHALLENGE
Salvia is a fast-growing and dynamic company; we are driven to make a difference for people living with severe migraines. With a focus on ongoing development, we are currently looking for a Clinical Research Associate. You will be part of the clinical team and able to work on clinical studies at various stages. The CRA plays a crucial role in ensuring the successful conduct of clinical trials by maintaining high standards of quality, compliance, and patient safety. You are passionate about clinical research and your dedication ensures our clinical studies are conducted with the highest quality and compliance.
RESPONSIBILITIES
Supporting study site selection and qualification; Developing and/or reviewing study documents for compliance with local and national clinical study requirements; Supporting regulatory submissions and site start-up (including preparation of study materials); Monitoring the study throughout its duration (initiation, interim, close-out), which involves visiting the study sites regularly; Reviewing study case report forms (CRF) completed by the sites towards the source data (SDR/SDV activities), and validating accurate source documentation to support CRF entries; Collaborating with study sites to ensure timely data entry and data cleaning; Regular remote monitoring to proactively identify potential risks and/or issues; Documenting site visits and issues in applicable reports and follow-up letters to the site; Supporting protocol and other study-related site training to ensure compliance and quality; Ensuring accurate and up-to-date study documentation (including TMF and study binders); Ensuring timely and compliant documentation and reporting to Regulatory Authorities and Ethics Committees/Institutional Review Boards (e.g. adverse event and device deficiency reporting); Ensuring compliance with all applicable local and national regulations; GDPR, GCP, company SOPs, study protocols, and relevant manuals.YOUR PROFILE
Minimum 2 years of experience in a comparable role. Fluent in Dutch and English. Frequent international travel required. Accurate, eye for detail, independent and pro-active attitude. Excellent communication skills, able to collaborate and build relationships with people across all levels. Bachelor's or master's degree in life sciences or relevant experience Knowledge of Good Clinical Practice (ICH, ISO 14155), Data Protection (GDPR) and Clinical Research laws and regulations.-
Senior Clinical Research Coordinator
3 weken geleden
Eindhoven, Noord-Brabant, Nederland Philips VoltijdJob TitleSenior Clinical Research CoordinatorJob DescriptionIn this role, you have the opportunity toSupport the European Clinical Operations department in executing international and national studies. Manage study documents, materials, devices, financial documents and clinical trial management systems. You will manage/oversee financial activities, while...
-
Senior Clinical Research Coordinator
4 weken geleden
Eindhoven, Nederland Philips VoltijdJob TitleSenior Clinical Research CoordinatorJob DescriptionIn this role, you have the opportunity toSupport the European Clinical Operations department in executing international and national studies. Manage study documents, materials, devices, financial documents and clinical trial management systems. You will manage/oversee financial activities, while...
-
Clinical AI Innovation Lead
4 weken geleden
Eindhoven, Nederland Philips VoltijdJob TitleClinical AI Innovation LeadJob DescriptionAs a Clinical AI Innovation Lead, you will be at the forefront of exploring and integrating generative AI technologies within our healthcare solutions. Your mission is to be the go-to person for these technologies, crafting cutting-edge solutions that address both clinical and business needs effectively....
-
JADS: Associate Professor in Data-Driven Entrepreneurship
3 weken geleden
Eindhoven, Nederland Eindhoven University of Technology VoltijdJob description Environment JADS Den Bosch closely collaborates with both Eindhoven University of technology and Tilburg University. This unique collaboration enables a true interdisciplinary approach building on deep technological and engineering knowledge combined with leading humanities and social sciences. In this joint appointment (e.g. 0.8...
-
Assistant Professor Design for Human-Vehicle interaction
4 weken geleden
Eindhoven, Nederland Eindhoven University of Technology VoltijdJob description Research: For this position, we are looking for a motivated colleague who will work on designing and evaluating solutions to overcome human factors issues in the domain of automated driving, such as trust and acceptance, shared control, situation awareness, automation surprise, perceived safety, uncertainty and the interaction between...
-
Assistant Professor in Sustainable Structural Design
5 dagen geleden
Eindhoven, Nederland TU Eindhoven Voltijd**Job description**: Sustainable structural design is a field that substantially contributes to the reduction of the environmental impact and CO2 footprint due to the construction of buildings and infrastructure. This can be achieved by various strategies: - optimization of structures e.g. by using parametric design and AI; - design of light-weight and/or...
-
Assistant Professor Design of Games and Digital Twins
4 weken geleden
Eindhoven, Nederland Eindhoven University of Technology VoltijdJob description Research: The department of Industrial Design of the TU/e, seeks to hire an assistant professor with expertise in human-computer interaction/ interactive systems design, and with a specific emphasis in the areas of game design, virtual worlds, and digital twins. The candidate is expected to strengthen the department’s competence in...
-
Modality Sales Specialist Image-Guided Therapy
4 weken geleden
Eindhoven, Nederland Philips VoltijdJob TitleModality Sales Specialist Image-Guided TherapyJob DescriptionYou will drive the overall Image-Guided Therapy (IGT) business in the Benelux by working directly with Installed Base customers and Inside Sales Team to promote Options, add-ons & Upgrades by converting opportunity to sales. You execute the strategy of Philips Customer Lifetime Value (CLV)...
-
Analytical Research Associate
4 weken geleden
Eindhoven, Nederland Science at Work Staffing VoltijdBedrijfsomschrijvingInternationaal biotechnologisch bedrijf dat zichspecialiseert in de ontwikkeling en productie van hoogwaardigefarmaceutische producten voor derde partijen. Ze zijn eenvooraanstaand bedrijf in de sector en zijn sterk aan het groeien opinternationaal niveau. FunctieomschrijvingJe gaat chromatografische methoden (LC-MS, GC-MS,etc.)...
-
Analytical Research Associate
4 weken geleden
Eindhoven, Nederland Science at Work Staffing VoltijdBedrijfsomschrijvingInternationaal biotechnologisch bedrijf dat zich specialiseert in de ontwikkeling en productie van hoogwaardige farmaceutische producten voor derde partijen. Ze zijn een vooraanstaand bedrijf in de sector en zijn sterk aan het groeien op internationaal niveau. FunctieomschrijvingJe gaat chromatografische methoden (LC-MS, GC-MS, etc.)...
-
Eindhoven, Nederland Eindhoven University of Technology VoltijdJob description Are you eager to develop the new research field of AI- based management system which in real time gives advice to travelers, transport providers and network managers to ultimately develop an efficient balance between transport demand and supply? Is your next dream move an Assistant Professor role within the research field of AI-based...
-
Assistant Professor – Urban Planning
4 weken geleden
Eindhoven, Nederland Eindhoven University of Technology VoltijdJob description Urban planning refers to a scientific approach to support multi-objective decisions concerning the location, size, and quality of a set of interconnected land uses; and this considers environmental, societal, cultural and economic perspectives, and people’s preferences, needs and behavior. The scientific orientation is reflected in...
-
Assistant Professor Data Interaction and Visual Analytics
4 weken geleden
Eindhoven, Nederland Eindhoven University of Technology VoltijdJob description Research: You have a design focus on data interaction, visual analytics, and information visualization, a keen sense of data quality and meaningful interactions with data. In Industrial Design, we look for effective and aesthetic ways of presenting large-scale, complex data to diverse audiences and to support various types of users. For...
-
PhD's on Decentralized AI for Audio-based Health Diagnostics
3 weken geleden
Eindhoven, Nederland Eindhoven University of Technology VoltijdJob description The Decentralized Artificial Intelligence Research Lab (DARL) at the Eindhoven University of Technology is seeking 2 talented and passionate Ph.D. candidates to join our team. These positions are part of the AiNed Fellowship project “Private Ears, Shared Insights” funded by the NWO. Our mission is to revolutionize the field of...
-
PhD Biodegradable/compostable Medical Patches | Eindhoven
3 weken geleden
Eindhoven, Nederland TNO VoltijdWhat will be your role? Remote health monitoring through medical patches in a patient's home shows great potential for the future, offering innovative diagnostic tools, enhanced treatments, and reduced hospital visits. These patches continuously track essential signs such as heart rate, breathing rate, and blood oxygen levels, enabling extended...
-
Eindhoven, Noord-Brabant, Nederland Eindhoven University of Technology VoltijdPosition PhD-studentIrène Curie Fellowship NoDepartment(s) Electrical EngineeringFTE 1,0Date off 16/06/2024Reference number V36.7451Job description Are you inspired by the prospect of shaping the future of automotive systems? Are you fascinated by the latest developments in intelligent autonomous vehicles? Are you excited to work on adaptive automotive E/E...
-
PhD "Organic neuromorphic and biohybrid spiking circuits”
3 weken geleden
Eindhoven, Nederland Eindhoven University of Technology VoltijdJob description Eindhoven University of Technology, Department of Mechanical Engineering, Institute for Complex Molecular Systems (ICMS) and Eindhoven Artificial Intelligence Systems Institute (EASI) have a vacancy for PhD project funded by the ERC Project NEURO-LABS to develop "Organic neuromorphic and biohybrid spiking circuits”. Project ...
